Cardinal Health 200, LLC: Medical Device Recall in 2025 - (Recall #: Z-1137-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB

Product Classification:

Class II

Date Initiated: November 8, 2024

Date Posted: February 19, 2025

Recall Number: Z-1137-2025

Event ID: 95947

Reason for Recall:

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Status: Ongoing

Product Quantity: 973,785 total units

Code Information:

1) ACDF PACK, UDI-DI:10195594353926 (each) 50195594353924 (case), Lot Number: J6935H; 2) ACDF PACK, UDI-DI:10195594439880 (each) 50195594439888 (case), Lot Number: J65K18;

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated